MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE; TRANSPORT CULTURE MEDIUM

Model Number	364958
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube device experienced stopper creep out or loose closure.The following information was provided by the initial reporter.The customer stated: problems with automated decapping of tubes.To solve this, the caps are very lightly tapped by hand, thus ventilating the tube.After this manipulation, the automatic processing of the tubes on the inoqula works without further problems.The difficulties with the automatic decapping of the 4 ml bd vacutainer urine tubes.
Additional Manufacturer Narrative
Bd had not received samples or photos for investigation of material # 364958, batch # 0227124.Therefore, 10 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to decapping as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube device experienced stopper creep out or loose closure.The following information was provided by the initial reporter.The customer stated: problems with automated decapping of tubes.To solve this, the caps are very lightly tapped by hand, thus ventilating the tube.After this manipulation, the automatic processing of the tubes on the inoqula works without further problems.The difficulties with the automatic decapping of the 4 ml bd vacutainer urine tubes.

• Brand Name: BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11935968
• Report Number: 1917413-2021-00483
• Device Sequence Number: 4323798
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: 50382903649582
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 364958
• Device Catalogue Number: 364958
• Device Lot Number: 0227124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1